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The InnerDyne, Inc., G-RED® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures.

• Percutaneous urological access, for typical procedures such as:
  • Percutaneous nephroscopy
  • Percutaneous bladder access (suprapubic)
• Percutaneous laparoscopic access to primary body cavities (i.e., abdominal and thoracic), both primary and secondary punctures; and
• Percutaneous access into hollow body organs.

The G-RED® device consists of an expandable dilator sheath assembly deployable via standard needle or cather/guidewire (Seldinger or similar) placement technique. The tubular member of the dilator assembly is configured so as to be axially compressed to reduce the outside than of the mandable sheath, penetrating the tissue into the target cavity (e.g., abdominal) or hollow organ. Upon use, the dilator assembly radially expands the walls of the surrounding tissue. This technique allows the user to benefit from the unique safety features and controllability of radial dilation by going from a less traumatic initial stick, followed by radial dilation to the dosire working channel. Once the working channel is established, the expandable should the working cannula in place to provide a sealed port for passage of diagnostic, therapeutic, and/or surgical instruments. This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments. The device is assembled from medical grade materials under GMP conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks. The G-RED® device is available in various lengths and working diameters to accommodate the selected size of indicated medical instruments. The subject product may be supplied in both disposable forms.

The provided text is a 510(k) premarket notification for a medical device called the "InnerDyne, Inc., Generic Radially Expanding Dilation, 'G-RED®' Device." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics.

Therefore, the document does not contain the kind of information typically found in a study demonstrating device performance against predefined acceptance criteria, especially not for AI/ML-based devices.

Here's why and what information can be extracted:

• Acceptance Criteria & Reported Device Performance: This document does not present explicit acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity, or surgical outcomes with numerical targets) nor does it provide a table of reported device performance in those terms. Instead, it argues for substantial equivalence to predicate devices.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set Info: These are all concepts related to clinical performance studies, particularly for diagnostic or AI/ML devices. Since this is a 510(k) for a mechanical dilation device, such studies are not typically required or presented. The focus is on design, materials, function, and safety, demonstrating they are similar to already approved devices.

Information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria/Goal: To demonstrate substantial equivalence in terms of basic design, product configuration, composition, utilized materials, function, deployment, warnings, precautions, contraindications, and intended use as compared to predicate devices.
   • Reported Device Performance: The document states that the G-RED® device is "as safe and effective as named predicates and currently marketed competitive devices for the stated indications." It does not provide quantitative performance data.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a test set of data/cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established for this type of submission.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. The type of ground truth used: Not applicable in the context of a typical performance study. The "ground truth" for this submission is essentially the proven safety and effectiveness history of the predicate devices.

8. The sample size for the training set: Not applicable. This is not a machine learning device.

9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Equivalence Argument (based on the provided text):

• Device Name: InnerDyne, Inc., Generic Radially Expanding Dilation, "G-RED®" Device
• Intended Use: Temporary dilation access for laparoscopic procedures (diagnostic, therapeutic, operative), percutaneous urological access (nephroscopy, suprapubic bladder access), percutaneous laparoscopic access to primary body cavities (abdominal and thoracic), and percutaneous access into hollow body organs.
• Substantial Equivalence Claimed Against:
  • InnerDyne, Inc., Step® device versions (for basic design, product configuration, composition, materials, function, deployment, warnings, precautions, contraindications, and intended use for access to abdominal/thoracic cavities).
  • InnerDyne, Inc., R.E.D.® device versions (for access to hollow body organs).
  • A number of currently marketed products with removable sheath design.
• Basis for Equivalence: Similarities in basic design, product configuration, composition, utilized materials, function, deployment, warnings and precautions, contraindications, and intended use.
• Manufacturing: Assembled from medical grade materials under GMP conditions; components molded and machined by qualified suppliers; assembled and secured by adhesives, welds, and mechanical interlocks.
• Conclusion: The submitter concludes the G-RED® device is "as safe and effective as named predicates and currently marketed competitive devices for the stated indications."

This document serves as a regulatory submission for market clearance based on substantial equivalence, not a clinical trial report with performance acceptance criteria.

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